A FDC is a combination of two or more actives in a fixed ratio. Co packaged products are also treated as FDCs.
The need of Fixed dose combinations (FDCs) is increasingly being felt as they improve adherence to treatment or the combination of actives works synergistically.
The Kokate Report which is an Indian policy guidance on approval of FDCS by CDSCO was released in June 2013.
As per the guidance for the approval of an FDC the following are a must:
1. Therapeutic rationalisation
2. Careful justification
3. Clinically relevant
The application for marketing authorization may comprise of
1. Original data
2. Data from literature
3. Hybrid: both original data and data from literature (most common)
However, quality data set will always be totally original
The SCOPE of the guidance is applicable to
1. import,
2. manufacture or
3. marketing approval of the FDC in India.
FDCs are classified into 4 main categories:
1. One or more active ingredients of the FDC is a new drug not approved india.
In this case FDC will be considered as an NCE and all requirements pertaining to an NCE will have to be fulfilled. Therefore a
Requirements will be as follows:
I. For phase I CT
1 .Data on animal pharmacology and Animal toxicology
2.protocol of phase I trial.
3. IB
4 . ICD
5. Copy of ethics committee approval letters
6. Registration number of the ethics committee
7. CRF
8. Undertaking by the Investigator and CO
9. Undertaking by the sponsor
I I. For phase 2 CT
1. Summary of the non clinical data with references
2 . results of the repeat dose systemic toxicity studies to support the duration of proposed human exposure.
3. Study report of Phase I study.
4. Phase 2 study protocol
5. IB,ICD, CRF, Copy of EC approvals, registration numbers of the ECs,
6. Investigator and sponsor undertaking.
I I I. Phase 3 CTs
1. Summary of non clinical data
2. Study reports of phase 1 and phase 2 studies,
3. Protocol, IB, ICD, CRF of phase 3 trial, EC approvals and registration numbers.
4. Undertaking by sponsor and investigators.
5. Prescribing information of the drug circulated in other countries , if any.
IV. Phase IV TRIALS
1 . drug approval details and conditions for marketing
2. Proposed protocol, IB, ICD, CRF,EC approval letters,registration number of ECs
3. Undertaking by investigator and sponsor
4. Prescribing information, post marketing data of the FDC, clinical data generated post grant of marketing authorization.
Certain exceptions to this rule include:
1 a. If the individual APIs of the proposdd FDC are already marketed in another country which has a regulatory system comparable to india.
1b. The FDC is marketed in india however one of the API is not approved for the indication or in the strength as in the proposed FDC.
1c. FDC is already marketed in india but a change in ratio of the active ingredients is sought in the proposed FDC.
The need of Fixed dose combinations (FDCs) is increasingly being felt as they improve adherence to treatment or the combination of actives works synergistically.
The Kokate Report which is an Indian policy guidance on approval of FDCS by CDSCO was released in June 2013.
As per the guidance for the approval of an FDC the following are a must:
1. Therapeutic rationalisation
2. Careful justification
3. Clinically relevant
The application for marketing authorization may comprise of
1. Original data
2. Data from literature
3. Hybrid: both original data and data from literature (most common)
However, quality data set will always be totally original
The SCOPE of the guidance is applicable to
1. import,
2. manufacture or
3. marketing approval of the FDC in India.
FDCs are classified into 4 main categories:
1. One or more active ingredients of the FDC is a new drug not approved india.
In this case FDC will be considered as an NCE and all requirements pertaining to an NCE will have to be fulfilled. Therefore a
Requirements will be as follows:
I. For phase I CT
1 .Data on animal pharmacology and Animal toxicology
2.protocol of phase I trial.
3. IB
4 . ICD
5. Copy of ethics committee approval letters
6. Registration number of the ethics committee
7. CRF
8. Undertaking by the Investigator and CO
9. Undertaking by the sponsor
I I. For phase 2 CT
1. Summary of the non clinical data with references
2 . results of the repeat dose systemic toxicity studies to support the duration of proposed human exposure.
3. Study report of Phase I study.
4. Phase 2 study protocol
5. IB,ICD, CRF, Copy of EC approvals, registration numbers of the ECs,
6. Investigator and sponsor undertaking.
I I I. Phase 3 CTs
1. Summary of non clinical data
2. Study reports of phase 1 and phase 2 studies,
3. Protocol, IB, ICD, CRF of phase 3 trial, EC approvals and registration numbers.
4. Undertaking by sponsor and investigators.
5. Prescribing information of the drug circulated in other countries , if any.
IV. Phase IV TRIALS
1 . drug approval details and conditions for marketing
2. Proposed protocol, IB, ICD, CRF,EC approval letters,registration number of ECs
3. Undertaking by investigator and sponsor
4. Prescribing information, post marketing data of the FDC, clinical data generated post grant of marketing authorization.
Certain exceptions to this rule include:
1 a. If the individual APIs of the proposdd FDC are already marketed in another country which has a regulatory system comparable to india.
1b. The FDC is marketed in india however one of the API is not approved for the indication or in the strength as in the proposed FDC.
1c. FDC is already marketed in india but a change in ratio of the active ingredients is sought in the proposed FDC.
